The FDA has approved an oral pellet formulation of Gilead Sciences' hepatitis C drug Epclusa for use in young children who cannot swallow tablets. Gilead secured approval for two strengths of the ...
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The oral pellets are supplied in unit-dose packets in 72mg, 96mg, 108mg, and 132mg dosage strengths and are expected to be available in April 2026. The Food and Drug Administration (FDA) has approved ...
Credit: Getty Images. The expanded approval was based on data from an open-label phase 2 trial that evaluated Epclusa in 41 patients 3 years to less than 6 years of age with chronic HCV infection. The ...
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BioCryst wins FDA approval for Orladeyo oral pellets
BioCryst Pharma (BCRX) announced on Friday that the U.S. Food and Drug Administration (FDA) approved an oral pellet formulation of its best-selling therapy, Orladeyo, as a once-daily preventive option ...
Advanced oral dosage forms allow for modulation of controlled- and sustained-release profiles. Multi-unit pellet systems (MUPS) and intelligently encapsulated mini-tablet systems (EMTS) have unique ...
The U.S. Food and Drug Administration (FDA) on Friday approved BioCryst Pharmaceuticals Inc.’s (NASDAQ: BCRX) New Drug Application (NDA) for the use of an oral pellet formulation of once-daily ...
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